The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with high-risk histology endometrial cancer and in patients with cervical cancer tumour size 2-4 cm.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
300
Sentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
Odense University Hospital
Odense, Denmark
Sensitivity
Sensitivity of sentinel lymph node mapping compared to the sensitivity of sentinel lymph node mapping combined with removal of PET-positive lymph nodes
Time frame: 2 years
Negative predictive value
Negative predictive value of sentinel lymph node mapping algorithm, and a sentinel lymph node mapping algorithm including removal of PET-positive lymph nodes
Time frame: 2 years
Specificity
Specificity of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes
Time frame: 2 years
Positive predictive value
Positive predictive value of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes
Time frame: 2 years
Prevalence of lymph node metastasis
Prevalence of lymph node metastasis in the pelvis and paraaortic area
Time frame: 2 years
Incidence of lymphedema
Using patient reported outcome measures
Time frame: 3 years
Severity of lymphedema
Using patient reported outcome measures
Time frame: 3 years
Quality of life rate
Using patient reported outcome measures
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Time frame: 3 years